A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,223
- 试验地点
- 1
- 主要终点
- Percentage of 12-Week CSBM Overall Responders
研究概览
简要总结
The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.
详细描述
The trial also included a 145 ug linaclotide treatment arm (an FDA-approved dose for CIC) as an established positive control to validate the study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has completed a colonoscopy if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
- •Patient has no clinically significant findings on a physical examination and clinical laboratory tests
- •Patient meets protocol criteria for CIC: reports < 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
- •Patient is compliant with daily interactive voice response system (IVRS) calls
- •Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.
排除标准
- •Patient has history of loose or watery stools
- •Patient has symptoms of or been diagnosed with irritable bowel syndrome (IBS)
- •Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
- •Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
- •Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.
研究组 & 干预措施
72 μg linaclotide
72 μg oral linaclotide, once daily for 12 weeks
干预措施: Linaclotide (Drug)
145 μg linaclotide
145 μg oral linaclotide, once daily for 12 weeks
干预措施: Linaclotide (Drug)
Placebo
matching placebo, once daily for 12 weeks
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Percentage of 12-Week CSBM Overall Responders
时间窗: Week 12
A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a bowel movement BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
次要结局
- Change From Baseline in 12-Week Abdominal Discomfort(Baseline, Week 1 to Week 12)
- Change From Baseline in 12-Week SBM Frequency Rate(Baseline, Week 1 to Week 12)
- Percentage of Month 1 CSBM Responders(Month 1)
- Percentage of Month 2 CSBM Responders(Month 2)
- Percentage of Month 3 CSBM Responders(Month 3)
- Change From Baseline in 12-Week CSBM Frequency Rate(Baseline, Week 1 to Week 12)
- Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation)(Week 12)
- Change From Baseline in 12-Week Stool Consistency Score(Baseline, Week 1 to Week 12)
- Change From Baseline in 12-Week Straining Score(Baseline, Week 1 to Week 12)
- Change From Baseline in 12-Week Abdominal Bloating(Baseline, Week 1 to Week 12)